(69 days)
The Arthrex FastThread™ Interference Screws are intended to be used for fixation of tissue, including ligament or tendon to bone, or a bone/tendon to bone. Interference fixation is appropriate for surgeries of the knee, shoulder, elbow, ankle, foot, and hand/wrist where the sizes offered are patient appropriate; specifically,
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle
Knee: Anterior Cruciate Ligament Repair, Posterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tenair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/wrist
The Arthrex FastThread™ Interference Screw is a cannulated, fully threaded, bioabsorbable interference screw, manufactured from PLDLA, Biphasic Calcium Phosphate and hydroxyapatite (HA). The screws measure 6-12 mm in diameter and 20-30 mm in length.
This document is a 510(k) premarket notification for the Arthrex FastThread™ Interference Screw, a medical device used for fixing tissue (ligament or tendon) to bone. It does not describe an AI/ML powered device, therefore the information requested about acceptance criteria and study data related to AI/ML device performance (such as sample size for test/training sets, expert qualifications for ground truth, MRMC studies, or standalone algorithm performance) is not applicable.
The provided text focuses on demonstrating the substantial equivalence of the new Arthrex FastThread™ Interference Screw to a previously cleared predicate device (Arthrex Interference Screw, K071176).
However, I can extract information related to the performance data and the conclusion on substantial equivalence, which serves a similar function to "acceptance criteria" and "proof of meeting criteria" in the context of this 510(k) submission.
Here's the relevant information:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Demonstrated Equivalence) | Reported Device Performance |
|---|---|
| Pullout strength at time zero | Statistically equivalent to the predicate device |
| Pullout strength after 16 weeks degradation | Statistically equivalent to the predicate device |
| Insertion performance | Statistically equivalent to the predicate device |
| Pyrogenicity (Bacterial Endotoxin) | Meets pyrogen limit specifications per EP 2.6.14/USP <85> |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided document.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The study was likely conducted in a laboratory setting for mechanical and biological testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a mechanical and biological testing study, not an AI/ML study requiring expert ground truth for interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable; this is not an AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable; this is not an AI-powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the pullout and insertion tests, the "ground truth" would be the objective measurements of force and resistance, typically compared against pre-defined engineering specifications or the performance of a predicate device.
- For bacterial endotoxin testing, the "ground truth" is compliance with a recognized standard (EP 2.6.14/USP <85>).
8. The sample size for the training set:
- Not applicable; this is not an AI-powered device using training data.
9. How the ground truth for the training set was established:
- Not applicable; this is not an AI-powered device.
Study Proving the Device Meets Acceptance Criteria:
The document states: "Pullout testing at time zero and after 16 weeks degradation and insertion testing was conducted to demonstrate that the proposed Arthrex FastThread™ Interference Screw performs statistically equivalent to the predicate. Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate that the device meets pyrogen limit specifications."
This indicates that mechanical tests (pullout strength, insertion performance) and a biological test (bacterial endotoxin) were performed. The "acceptance criteria" here are framed in terms of statistical equivalence to the predicate device for mechanical properties and meeting established pyrogen limits for biological safety. The conclusion drawn is that "Based on the indications for use, technological characteristics, and the summary of data submitted, Arthrex Inc. has determined that the proposed device is substantially equivalent to the currently marketed predicate device."
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".
May 22, 2018
Arthrex Inc. Jessica L. Singelais Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K180662
Trade/Device Name: Arthrex FastThread™ Interference Screw Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI, HWC Dated: April 19, 2018 Received: April 23, 2018
Dear Ms. Singelais:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K180662
Device Name Arthrex FastThread™ Interference Screw
Indications for Use (Describe)
The Arthrex FastThread™ Interference Screws are intended to be used for fixation of tissue, including ligament or tendon to bone, or a bone/tendon to bone. Interference fixation is appropriate for surgeries of the knee, shoulder, elbow, ankle, foot, and hand/wrist where the sizes offered are patient appropriate; specifically,
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle
Knee: Anterior Cruciate Ligament Repair, Posterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tenair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/wrist
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| Date Prepared | May 17, 2018 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Jessica L. Singelais |
| Regulatory Affairs Specialist | |
| 1-239-598-4302, ext. 73091 | |
| Jessica.singelais@arthrex.com | |
| Name of Device | Arthrex FastThread™ Interference Screw |
| Common Name | Screw, fixation, bone |
| Product Code | MAI, HWC |
| Classification Name | 888.3030 Single/multiple component metallic bone fixation appliances and |
| accessories | |
| 888.3040 Smooth or threaded metallic bone fixation fastener | |
| Regulatory Class | II |
| Predicate Device | K071176: Arthrex Interference Screw |
| Purpose of | This Special 510(k) premarket notification is submitted to obtain clearance for a |
| Submission | line extension to the Arthrex BioComposite Interference Screw family cleared |
| under K071176. | |
| Device Description | The Arthrex FastThread™ Interference Screw is a cannulated, fully threaded,bioabsorbable interference screw, manufactured from PLDLA, Biphasic Calcium |
| Phosphate and hydroxyapatite (HA). The screws measure 6-12 mm in diameter | |
| and 20-30 mm in length. | |
| Indications for Use | The Arthrex FastThread Interference Screws are intended to be used for fixation |
| of tissue, including ligament or tendon to bone, or a bone/tendon to bone. | |
| Interference fixation is appropriate for surgeries of the knee, shoulder, elbow, | |
| ankle, foot, and hand/wrist where the sizes offered are patient appropriate; | |
| specifically, | |
| Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps | |
| Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or | |
| Capsulolabral Reconstruction | |
| Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, | |
| Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament | |
| Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon | |
| transfers in the foot and ankle | |
| Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, | |
| Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique | |
| Ligament Repair, Illiotibial Band Tenodesis, Posterior Cruciate Ligament Repair | |
| Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament | |
| Reconstruction | |
| Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament | |
| Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint | |
| arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions | |
| and repairs, tendon transfer in the hand/wrist |
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| ComparisonSummary ofTechnologicalCharacteristics andModificationsProposed | The proposed and predicate devices have the same technological characteristics.The proposed devices consist of a line extension to the predicate, which includeminor dimensional modifications, added fenestrations and a change in headprofile with no change in intended use or function.The Arthrex FastThread™ Interference Screw is substantially equivalent to thepredicate device in which the basic design features and intended uses are thesame. Any differences between the proposed device and the predicate device areconsidered minor and do not raise questions concerning safety or effectiveness. |
|---|---|
| Performance Data | Pullout testing at time zero and after 16 weeks degradation and insertion testingwas conducted to demonstrate that the proposed Arthrex FastThread™Interference Screw performs statistically equivalent to the predicate.Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate thatthe device meets pyrogen limit specifications. |
| Conclusion | Based on the indications for use, technological characteristics, and the summaryof data submitted, Arthrex Inc. has determined that the proposed device issubstantially equivalent to the currently marketed predicate device. |
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.